clinical evaluation of patients with everolimus-eluting stent xience v® implanted in the treatment of restenosis in non-coated metallic stent (bms in-stent restenosis) during a 2 year clinical follow-up period

Conditions: Coronary Restenosis

Summary: interventional, prospective, non-randomized, non-comparative, open and multicentric study of patients with everolimus-eluting stent " xience v® " implanted in the treatment of restenosis in non-coated metallic stent (bms in-stent restenosis) during a 2 year clinical follow-up period.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older * patients affiliated to a social security or equivalent regimen * patients agreeing to participate in the study (patient with signed informed consent ) * patients with evidence of myocardial ischemia (stable or unstable angina, silent ischemia, positive functional exploration or a reversible modification in the ecg consistent with ischemia). * patient acceptable candidate for cabg surgery * patient agreeing to undergo all protocol scheduled follow-up examinations. * patients who tolerate the association aspirin (dosed 75 to 160 mg/day) and clopidogrel at 75 mg/day for at least 6 months angiographic inclusion criteria: * patient with de novo and sole in-stent restenosis (focal, diffuse or proliferative) in a non-coated metallic stent with or without any other coronary lesions. * patient with target reference vessel diameter between 2.5 and 4 mm by visual estimate * patient with a target lesion ≤ 22mm by visual estimate * patient with a target lesion in an artery with a visual estimate of the restenosis between 50 and 99% and a timi flow grade \> 1 * patient with multiple lesions, the other lesions have been treated with success exclusion criteria: * patient in emergency * patient pregnant * patient nursing * patient unable to give informed consent personally. * patient with myocardial infarction within the previous 72 hours. * patient with limited life expectancy (lesser than 1 year post-inclusion) * patient with unstable arrhythmia * patient with left ventricular ejection fraction (lvef) lesser than 30% * patient receiver of a cardiac or any other organ transplantation or candidate to an organ transplant * patient who receive or scheduled to receive chemo- or radio- therapy within the 30 days prior to any protocol-related procedure. * patient treated with immunosuppressives or for known immunodepressive or auto-immune pathologies * patient receiving chronically anticoagulant therapy with an inr greater than 2.5 * patient with known hypersensitivity or contraindications to anti-platelet drugs, everolimus, heparin, chromium cobalt alloys, nickel, tungsten, acrylic- or fluoro- polymers or sensitivity to angiographic contrast agents. * patient with planned elective surgery requiring the interruption or discontinuation of anti-platelet therapy. * patient with platelet count \ 700 000mm3 ; wbc counts \<3 000/mm3 or known or suspected liver disease * patient with severe renal insufficiency (creatinine clearance rate \< 30 ml/min), or under dialysis * patient with an history of coagulopathy refusing blood transfusion * patient who had a stroke/cerebrovascular accident or transient cerebrovascular ischemia in the preceding 6 months * patient with urinary or gastro-intestinal bleed in the preceding 6 months * patient with other known serious medical illness or known history of substance abuse (alcohol, drugs) that might result in non-compliance to the investigational plan, or interfere with the results or diminish the life expectancy to less than a year. * patient enrolled in an interventional study with another medical device or drug angiographic exclusion criteria * patient with in-stent restenosis located on the left main on the coronary by-pass * patient with a lesion of the in-stent restenosis located in a bifurcation including a lateral branch of diameter \> 1.5mm * patient with the target vessel totally occluded * patient with a lesion of the restenosis previously treated with another device (with the exception of balloon-tipped catheter) such as a cutting balloon, an atherectomy, laser, brachytherapy or any another medicated stent. * patient with thrombus in the target vessel * patient with aorto-ostiale lesions * patient with previous failures of multiple lesions treated by angioplasty.

Keywords: drug eluting stent stents angioplasty chronic coronary occlusion stent thrombosis vascular disease myocardial ischemia coronary artery stenosis coronary disease coronary artery disease coronary restenosis